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- Global Regulatory Solutions
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General Information
Useful files and examples provided by Global Regulatory Solutions. If you need something that is not here, please let us know and we will see what we can do to help.
Moderator: erodriguez - 3 Topics
- 3 Posts
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Last post by erodriguez
Sat Aug 14, 2010 1:52 pm
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General Information
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Regulatory Affairs
Post your questions and concerns about regulatory affairs. We will address these concerns on a regular basis within this forum.
Moderator: erodriguez - 3 Topics
- 3 Posts
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Last post by erodriguez
Mon Nov 22, 2010 12:01 am
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Regulatory Affairs
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Validation Concerns
This forum is designed to address various validation and verification concerns. Here, we can discuss anything from Product, Process, and non-product application validations. We can also discuss Code Reviews, Unit Testing, and other forms of Verification.
Moderator: erodriguez - 1 Topics
- 1 Posts
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Last post by erodriguez
Wed Aug 11, 2010 2:29 pm
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Validation Concerns
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Part 11
21 CFR Part 11 is often a big concern in the medical device community. We can discuss your concern here and help you understand how best to approach Part 11.
Moderator: erodriguez - 1 Topics
- 1 Posts
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Last post by erodriguez
Wed Aug 11, 2010 2:34 pm
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Part 11
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Wireless Technology
Wireless technology in medical devices is a growing concern with the FDA. In response, the FDA has issued a new draft guidance. Lets discuss this concern here.
Moderator: erodriguez - 1 Topics
- 1 Posts
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Last post by erodriguez
Wed Aug 11, 2010 2:40 pm
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Wireless Technology
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